WZ SELF-EXPANDING STENT TRANSHEPATIC BILIARY SYSTEM

Stents, Drains And Dilators For The Biliary Ducts

ABBOTT VASCULAR INC.

The following data is part of a premarket notification filed by Abbott Vascular Inc. with the FDA for Wz Self-expanding Stent Transhepatic Biliary System.

Pre-market Notification Details

Device IDK031331
510k NumberK031331
Device Name:WZ SELF-EXPANDING STENT TRANSHEPATIC BILIARY SYSTEM
ClassificationStents, Drains And Dilators For The Biliary Ducts
Applicant ABBOTT VASCULAR INC. 400 Saginaw Drive Redwood City,  CA  94063
ContactJoanna Kuskowski
CorrespondentJoanna Kuskowski
ABBOTT VASCULAR INC. 400 Saginaw Drive Redwood City,  CA  94063
Product CodeFGE  
CFR Regulation Number876.5010 [🔎]
DecisionSe - With Limitations (SESU)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-04-28
Decision Date2003-08-12
Summary:summary

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